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news.The European Commission has cleared the expanded use of Genzyme's Thyrogen (thyrotropin alfa) cancer therapy for patients with postoperative thyroid remnant ablation.
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The new approval allows administration of a reduced dose of radioiodine from the range of 30 to 100mCi versus the previously specified amount of 100mCi.
Revised indication for use of Thyrogen in Europe is supported by the results of the two studies, HiLo and ESTIMABL, conducted in thyroid remnant ablation.
University Paris Sud, Paris, France, Institut Gustave Roussy professor Martin Schlumberger said, "The expanded Thyrogen indication provides a new option for many physicians who may be reducing radioiodine use due to uncertainty about impact on recurrences and mortality in low-risk patients as well as short- and long-term safety concerns."
The 30mCi of radioiodine was well tolerated and exhibited similar success rates for low-dose radioiodine in addition to rhTSH against high-dose plus THW or rhTSH in both the studies.